DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
Sponsor
Gilead Sciences (Industry)
Overall Status
Terminated
CT.gov ID
NCT00353574
Collaborator
(none)
282
75
3
43
3.8
0.1
Study Details
Study Description
Brief Summary
This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
282 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311-E)
Study Start Date
:
Sep 1, 2006
Actual Primary Completion Date
:
Feb 1, 2010
Actual Study Completion Date
:
Apr 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Darusentan 50 mg Darusentan 50 mg administered orally once daily |
Drug: Darusentan
Darusentan capsules administered orally once daily
|
| Experimental: Darusentan 100 mg Darusentan 100 mg administered orally once daily |
Drug: Darusentan
Darusentan capsules administered orally once daily
|
| Experimental: Darusentan 300 mg Darusentan 300 mg administered orally once daily |
Drug: Darusentan
Darusentan capsules administered orally once daily
|
Outcome Measures
Primary Outcome Measures
- Change in trough sitting systolic and diastolic blood pressure [Baseline to Week 14]
Secondary Outcome Measures
- Change in mean 24-hour systolic and diastolic ambulatory blood pressures. [Baseline to Week 14]
- Percentage of subjects who reach systolic blood pressure goal [Week 14]
- Change in estimated glomerular filtration rate (eGFR) [Baseline to Week 14]
Eligibility Criteria
Criteria
Ages Eligible for Study:
35 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects who have completed the Treatment Period of clinical trial DAR-311
-
Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
Exclusion Criteria:
-
Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related adverse event (AE)
-
Treatment with another endothelin receptor antagonist within 6 months of study entry
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Comprehensive Heart Failure Center | Mobile | Alabama | United States | 36608 |
| 2 | Canyon Clinical Research | Tucson | Arizona | United States | 85712 |
| 3 | Chrishard Medical Group | Inglewood | California | United States | 90301 |
| 4 | VA Medical Center - WLA | Los Angeles | California | United States | 90073 |
| 5 | Sacramento Heart and Vascular | Sacramento | California | United States | 95825 |
| 6 | Apex Research Institute | Santa Ana | California | United States | 92705 |
| 7 | Complete Renal Care | Denver | Colorado | United States | 80220 |
| 8 | Connecticut Clinical Research, LLC | Bridgeport | Connecticut | United States | 06606 |
| 9 | MedStar Diabetes Institute at Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 10 | White-Wilson Medical Center | Fort Walton Beach | Florida | United States | 32569 |
| 11 | A.G.A. Clinical Trials | Hialeah | Florida | United States | 33012 |
| 12 | Jacksonville Center for Clinical | Jacksonville | Florida | United States | 32216 |
| 13 | Ricardo A. Bedoya, Cardiology | Jupiter | Florida | United States | 33458 |
| 14 | International Research Association | Miami | Florida | United States | 33156 |
| 15 | Cardiovascular Center of Sarasota | Sarasota | Florida | United States | 34231 |
| 16 | Tampa Bay Nephrology Associates, PL | Tampa | Florida | United States | 33603 |
| 17 | Metabolic Research Institute, Inc. | West Palm Beach | Florida | United States | 33401 |
| 18 | Global Research Partners | Calhoun | Georgia | United States | 30701 |
| 19 | Kula Research | Honolulu | Hawaii | United States | 96816 |
| 20 | Chicago Heart & Vein Clinic | Elk Grove Village | Illinois | United States | 60007 |
| 21 | Evanston Northwestern Healthcare | Evanston | Illinois | United States | 60201 |
| 22 | Clinical Investigation Specialists, Inc. | Gurnee | Illinois | United States | 60031 |
| 23 | Midwest Heart Foundation | Lombard | Illinois | United States | 60148 |
| 24 | Medical Research Institute | Slidell | Louisiana | United States | 70458 |
| 25 | Androscoggin Cardiology Associates | Auburn | Maine | United States | 04210 |
| 26 | Maine Research Associate | Auburn | Maine | United States | 04210 |
| 27 | Cardiovascular Consultants of Maine | Scarborough | Maine | United States | 04074 |
| 28 | Clinical Associates | Reisterstown | Maryland | United States | 21136 |
| 29 | Rockville Internal Medicine Group | Rockville | Maryland | United States | 20854 |
| 30 | Professional Clinical Research | Benzonia | Michigan | United States | 49616 |
| 31 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 32 | Professional Clinical Research | Interlochen | Michigan | United States | 49643 |
| 33 | Specialty Medical Center | Pahrump | Nevada | United States | 89048 |
| 34 | Physicians East, PA | Greenville | North Carolina | United States | 27834 |
| 35 | The Lindner Clinical Trial Center | Cincinnati | Ohio | United States | 45219 |
| 36 | COR Clinical Research | Oklahoma City | Oklahoma | United States | 73003 |
| 37 | Southwest Cardiology Associates | Oklahoma City | Oklahoma | United States | 73109 |
| 38 | Castlerock Clinical Research Consultants | Tulsa | Oklahoma | United States | 74136 |
| 39 | Hillsboro Cardiology, PC | Hillsboro | Oregon | United States | 97123 |
| 40 | Northeast Clinical Research Centers, Inc. | Allentown | Pennsylvania | United States | 18103 |
| 41 | Heritage Cardiology Associates | Camp Hill | Pennsylvania | United States | 17011 |
| 42 | Brandywine Clinical Research | Downingtown | Pennsylvania | United States | 19335 |
| 43 | Green and Seidner Family Practice Associates | Lansdale | Pennsylvania | United States | 19446 |
| 44 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
| 45 | RI Hospital | Providence | Rhode Island | United States | 02903 |
| 46 | Neem Research Group, Inc. | Columbia | South Carolina | United States | 29201 |
| 47 | Internal Medicine & Industrial Medicine | Desoto | Texas | United States | 75115 |
| 48 | T&R Clinical, P.A. | Ft Worth | Texas | United States | 76117 |
| 49 | Pri-Med Care | Lewisville | Texas | United States | 75067 |
| 50 | Innovative Clinical Trials | San Antonio | Texas | United States | 78229 |
| 51 | Burke Internal Medicine, Inc. | Burke | Virginia | United States | 22015 |
| 52 | Manassas Clinical Research Center | Manassas | Virginia | United States | 20110 |
| 53 | Liberty Research Center | Tacoma | Washington | United States | 98405 |
| 54 | CIMEL | Buenos Aires | Argentina | ||
| 55 | DIM (Clinica Privada) | Buenos Aires | Argentina | ||
| 56 | Fundapres | Buenos Aires | Argentina | ||
| 57 | Hospital Britanico de Buenos Aires | Buenos Aires | Argentina | ||
| 58 | Hospital Jose Maria Ramos Meijia | Buenos Aires | Argentina | ||
| 59 | Hospital Municipal Bernardo Houssay | Buenos Aires | Argentina | ||
| 60 | Medeos | Buenos Aires | Argentina | ||
| 61 | Sanatorio Municipal | Buenos Aires | Argentina | ||
| 62 | Centro Integrado Hospital do Rim e Hipertensao | Sao Paulo | Brazil | ||
| 63 | Centro Integrado Hospital | Sao Paulo | Brazil | ||
| 64 | Cambridge Cardiac Care Center | Cambridge | Ontario | Canada | N3H 3R8 |
| 65 | Clinical Research Solutions | Kitchener | Ontario | Canada | N2G 1G5 |
| 66 | Hvidovre Hospital | Hvidovre | Denmark | ||
| 67 | Bispebjerg Hospital | København | Denmark | ||
| 68 | CIC Hopital Jeanne D'Arc | Dommartin les Toul | France | ||
| 69 | CHU de Grenoble | Grenoble Cedex | France | ||
| 70 | Hôpital Civil, Service HTA maladies vasculaires | Strasbourg Cedex | France | ||
| 71 | Cardiovascular Research, Karolinska Institue | Stockholm | Sweden | ||
| 72 | University Hospital Umea | Umea | Sweden | ||
| 73 | Townhead Surgery | Scotland | United Kingdom | ||
| 74 | Avenue Surgery | Wiltshire | United Kingdom | ||
| 75 | Hathaway Medical Centre | Wiltshire | United Kingdom |
Sponsors and Collaborators
- Gilead Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00353574
Other Study ID Numbers:
- DAR-311-E
First Posted:
Jul 18, 2006
Last Update Posted:
Mar 18, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Gilead Sciences
Additional relevant MeSH terms: